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Content

Good Manufacturing Practice


Sterile Production




AUTOCLAVES - THE SCIENCE OF STERILIZING

Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.

This program examines the science involved in achieving sterility and some of the pitfalls that await unwary users of autoclaves.

Content includes: About autoclaves; The science of killing microorganisms; Air and temperature; Porous loads; Laboratory science - Biological indicators.

Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.


DVD-ROM / 2010 / () / 22 minutes

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AUTOCLAVES - THE STERILIZATION PROCESS

Autoclaves are used primarily to sterilize finished medicines that are sealed in their final containers and media and equipment used in microbiological laboratories, as well as a variety of things used in aseptic manufacture.

This second program on steam sterilization examines the practice of autoclave use - the working of the whole sterilization process.

Content includes: The sterilization elements; Validation principles; Sterility assurance; Determining loading patterns and cycles; Validation specifics; Re-qualification of autoclave processes.

Complete with full documentation - transcript, glossary of terms, printable multiple choice knowledge test, presentation summary sheets and editable QuestionMaster quiz software.


DVD-ROM / 2010 / () / 24 minutes

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HEAT STERILIZATION

Widely adopted, where possible, as the sterilization method of choice, the module provides a basic understanding of heat sterilization and provides an overview of what it is and how it works. Topics are: why sterile; microorganisms; validation; operations; documentation; people.

DVD-ROM / 1996 / () / 19 minutes

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UNDERSTANDING IRRADIATION

The development of products made from heat sensitive materials necessitated the availability of 'cold' sterilization. lonizing radiation, using gamma rays or electron beam are such processes, for use in all healthcare manufacturing, medical device and food industries. Includes: why cold processes?; why radiation works; the technology; the process; the sterilizing dose; validation; people.

DVD-ROM / 1996 / () / 26 minutes

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AUDITING STERILE PRODUCTION AREAS

Content includes: Access to Aseptic Manufacturing Areas; General Overview of the Facility; Air Filtration and Pressure Differentials; Requirements for Areas within Aseptic Manufacturing; Equipment for Aseptic Manufacture; Monitoring of Aseptic Areas; Validation; Personnel; Filtration; Testing. Includes interactive FDA and EU GMP regulations.

DVD-ROM / / () / 25 minutes

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INTRODUCTION TO STERILE & ASEPTIC PRODUCTION

A completely new visualization of core sterile learning module with intelligent assessment to promote the performance and quality required in sterile and aseptic environments.

This program is an introduction to the subject illustrating the reasons for, and the controls related to, sterile and aseptic production. The subject chapter headings are:

~ Introduction
~ The Contaminants
~ Sterile Production
~ Clean Environments
~ Personnel & Sterility
~ Cleaning & Disinfection
~ Preparation & Processing
~ Methods of Sterilization


DVD-ROM / / () /

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PREPARING & GOWNING FOR STERILE PRODUCTION

Making parenteral [sterile] drugs or medical devices requires the greatest dedication to training. It is essential to follow stringent preparation and gowning protocols before entering a sterile environment.

This program follows the training of newcomers to sterile production as they learn the background to sterile and aseptic operations and then how to prepare and dress for working in this very special environment. The program includes:

Part 1: Introduction
Part 2: Contamination control & cleanrooms
Part 3: The preparation & gowning protocol
Part 4: Leaving the cleanroom
Part 5: Summary


DVD-ROM / / () / 19 minutes

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